cGMP manufacturing for clinical and commercial supply

cGMP Manufacturing

Our Dedication to Manufacturing Excellence

As a developer and contract manufacturer operating several multi-product facilities, we are, of course, approved in current Good Manufacturing Practice (cGMP). Specialized staff, systems and procedures ensure robust process performance and optimized late-stage and commercial processes. Our dedication to reliability and operational excellence is expressed in our track record: More than 30 products successfully brought to market, an average of 5 authorities inspections per year, regular site audits by customers and an excellent standing with all relevant regulatory authorities.

Our track record proves our expertise for commercial supply 

With our wide portfolio of upstream and downstream processing technologies, including fully disposable single-use bioreactor systems, we are capable of meeting our customers’ high demands on flexibility and productivity. We are the single, integrated manufacturer of various market products for customers all over the world. Processes transferred into the large-scale cGMP facility are suitable for Phase III clinical studies, launch and commercial supply. We have also successfully performed the validation and authorities’ registration of several 2nd and 3rd generation processes. Verification, e.g. in cell cultures, can be performed at the Manufacturing Science and Technology department in small scale systems, prior to applying it at scale.

Fully integrated continuous manufacturing

In addition to our 24/7 running mode in our facilities in Fremont, CA (USA), and Biberach (Germany), we also offer fully integrated continuous manufacturing in Fremont, CA. We developed this technology to offer advantages to a number of new molecule formats and manufacturing processes. Benefits include an increase of productivity in upstream for low titer processes as well as simplified purification because of relatively homogeneous protein material. On top of that it gives us the opportunity to maximize the use of column capacity and lifetime and reduce buffer consumption.

Our established and proprietary technologies are at your disposal.

How we ensure manufacturing excellence?

  • Impeccably clean and hygienic manufacturing area
  • Controlled environmental conditions
  • Control of all manufacturing process steps by a validated DCS (Distributed Control System) and LIMS (Laboratory Information Management System)
  • State-of-the-art statistical analysis and trending software to routinely monitor and evaluate processes
  • Standard operating procedures (SOPs) according to Good Documentation Practice
  • Continuous improvement through internal audits and external consultancy
  • Regular customer audits
  • Scale-up capacity from 80 to 15,000 liters per train
  • Total volume amounts more than 300,000 liters
  • Downstream processing matched to the upstream scale
  • Plant operated by a validated process control system
Ensuring robust process performance and optimized late stage processes